SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE

K980313 · Schwartz Electro-Optics, Inc. · GEX · Mar 19, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980313
• Device Name: SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE
• Applicant: Schwartz Electro-Optics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, menisous, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles.

Device Story

The Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase is a pulsed laser system emitting at 2940 nm. It utilizes a visible aiming beam to guide the treatment laser. The device is operated by clinicians in surgical settings to cut, vaporize, ablate, or coagulate soft tissue and cartilage. It supports various repetition rates in pulsed mode. The system is used across multiple surgical specialties, including dermatology for skin resurfacing and wrinkle treatment. The clinician directs the laser beam to the target tissue; the laser energy interacts with the tissue to achieve the desired surgical effect. The device is intended for prescription use only.

Clinical Evidence

No clinical data was presented. Substantial equivalence is based on technological and intended use similarities to predicate devices.

Technological Characteristics

Pulsed Erbium laser system; 2940 nm wavelength; visible aiming beam; pulsed mode operation with variable repetition rates. Class II device.

Indications for Use

Indicated for surgical procedures (incision, excision, vaporization, ablation, coagulation) of soft tissue and cartilage, including skin, muscle, organs, and glands. Applicable to arthroscopy, laparoscopy, and skin resurfacing/wrinkle treatment. Specialties include General, Plastic, Podiatry, Urology, Gynecology, Pulmonary, Dermatology, Gastroenterology, Ophthalmology, ENT, Thoracic, and Oral/Maxillofacial surgery. Prescription use only.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase (K974039)
• Sharplan 4020 Erbium Surgical Laser (K971648)

Submission Summary (Full Text)

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K980313

MAR 1 9 1998

## 510(k) Summary of Safety and Effectiveness The Schwartz Electro-Optics, Inc. Model CLR 2940 Erbium CrystaLase

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the following: the Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase (K974039) and the Sharplan 4020 Erbium Surgical Laser (K971648).

- Schwartz Electro-Optics, Inc. I. Company: 3404 North Orange Blossom Trail Orlando, FL 32804 Timothy J. Shea, Senior Director 1/15/98
- Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase II. Model:
- III. Predicate Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase (K974039), Devices: and the Sharplan 4020 Erbium Surgical Laser (K971648).
- The Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase is a IV. Description: medical device which is capable of emitting a pulsed treatment laser beam at a wavelength of 2940 nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.

## V. Indications

The Schwartz Electro-Optics, Inc. CLR 2940 is indicated for all surgical for Use: procedures for cutting (incision/excision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. No new indications were sought in this premarket notification and no clinical data was presented.

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- From a design and clinical perspective, the predicate and candidate laser VI. Summary: devices, are of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Schwartz Electro-Optics, Inc. believes that no significant differences exist. Therefore, the Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase should not raise any concerns regarding its overall safety and/or effectiveness.
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- Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1998

Mr. Timothy J. Shea Senior Director Schwartz Electro-Optics, Incorporated 3404 North Orange Blossom Trail Orlando, Florida 32804

Re: K980313 Schwarts Electro-Optics, Inc. CLR 2940 Trade Name: Erbium CrystaLase Requlatory Class: II Product Code: GEX Dated: January 27, 1998 Received: January 27, 1998

Dear Mr. Shea:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Shea

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Stephen Rhodes

M. Witten, Ph.D., M.D. irector Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K9/03/3

Food and Drug Administration Center of Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ - 401) 9200 Corporate Boulevard Rockville, Maryland 20850

300 / HAG

## Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase Indications for Use

As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, menisous, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles.

Specialties are:

- * General Surgery
- * Plastic Surgery,
- * Podiatry
- * Urology
- * Gynecology
- * Pulmonary Surgery
- * Dermatology
- * Gastroenterology
- * Ophthalmology
- * ENT
- * Thoracic Surgery
- * Oral and Maxillofacial Surgery

These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. is simply requesting the addition of skin resurfacing and the treatment of wrinkles.

Stephen Rhodes

(Division Sign-Off Division of General Restorative Device 510(k) Number

Prescription Use X
(Per 21 CFR 801.109)

Over-the-Counter Use_

SK-28